(297 days)
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Not Found
No
The provided text describes a TENS/EMS/NMES device with standard indications for use. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the therapeutic applications of electrical stimulation.
Yes
The text explicitly states its use for "temporary relief of pain," "symptomatic relief of chronic intractable pain," "post traumatic pain," "post surgical pain," "relaxation of muscle spasm," and "muscle re-education," which are all therapeutic applications.
No
Explanation: The provided text describes the intended use of the device for pain relief, muscle stimulation, and improving muscle performance, which are therapeutic applications. There is no mention of the device being used to diagnose a medical condition or disease.
No
The intended use describes a TENS/EMS/NMES device, which are typically hardware-based devices that deliver electrical stimulation. The summary does not provide a device description to indicate otherwise.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a device that uses TENS (Transcutaneous Electrical Nerve Stimulation) and EMS/NMES (Electrical Muscle Stimulation/Neuromuscular Electrical Stimulation). These are methods of applying electrical currents to the body for therapeutic purposes.
- Intended Use: The intended uses listed are for pain relief, muscle stimulation, and related physical therapy applications. None of these involve the analysis of specimens taken from the body.
Therefore, this device falls under the category of a physical therapy or pain management device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Over-The-Counter Use:
TENS:
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, arm,and leg, due to strain from exercise or normal household and work activities.
EMS/NMES:
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Prescription Use:
TENS:
1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
EMS/NMES:
1)Relaxation of muscle spasm;
2)Increase of local blood flow circulation;
3)Prevention or retardation of disuse atrophy;
4)Muscle re-education:
5)Maintaining or increasing range of motion;
6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Product codes (comma separated list FDA assigned to the subject device)
NUH NGX IPF GZJ
Device Description
Wireless TENS & EMS (Model SM9110, SM9113, SM9116)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
shoulder, wast, back, arm, and leg, calf muscles
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 19, 2024
Chongqing Rob Linka Science And Technology Co., Ltd. % Doris Dong General Manager Shanghai CV Technology Co., Ltd. Room 602, No. 19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China
Re: K233067
Trade/Device Name: Wireless TENS & EMS (Model SM9110, SM9113, SM9116) Regulation Number: 21 CFR 882.5890; 890.5850 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH NGX IPF GZJ Dated: June 18, 2024 Received: June 20, 2024
Dear Doris Dong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Kang -S
for Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K233067
Device Name
Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
Indications for Use (Describe) Over-The-Counter Use:
TENS:
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, arm,and leg, due to strain from exercise or normal household and work activities.
EMS/NMES:
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Prescription Use:
TENS:
1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
EMS/NMES:
1)Relaxation of muscle spasm;
2)Increase of local blood flow circulation;
3)Prevention or retardation of disuse atrophy;
4)Muscle re-education:
5)Maintaining or increasing range of motion;
6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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